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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NC EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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BOSTON SCIENTIFIC CORPORATION NC EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Device Problem Material Integrity Problem (2978)
Patient Problem Perforation of Vessels (2135)
Event Date 10/01/2018
Event Type  Injury  
Event Description
It was reported that shaft rupture and vessel perforation occurred.The target lesion was located in the svt.An nc emerge balloon catheter was advanced for post-dilatation of a stent.However, the shaft of the device ruptured 1-2 inches proximal to the balloon causing vessel perforation.No further patient complications were reported and the physician was able to continue treating the patient.
 
Manufacturer Narrative
Date of event: during summer, but used the first date of the month of the aware date as no specific date was provided.This supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on 12/14/2018 01:02 pm ct.The report number is being corrected from: 2134265-2018-64207 to: 2134265-2018-63142.
 
Event Description
It was reported that shaft rupture and vessel perforation occurred.The target lesion was located in the svt.An nc emerge balloon catheter was advanced for post-dilatation of a stent.However, the shaft of the device ruptured 1-2 inches proximal to the balloon causing vessel perforation.No further patient complications were reported and the physician was able to continue treating the patient.It was further reported that the target lesion was located in svg (saphenous vein graft) and not svt.
 
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Brand Name
NC EMERGE
Type of Device
CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8098925
MDR Text Key128190292
Report Number2134265-2018-63142
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 01/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received11/26/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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